Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07315555

Acronym

Asthma

Enrollment

Registered

2026-01-02

Start date

2026-01-01

Completion date

2026-10-31

Last updated

2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Pneumonia

Keywords

Nigella sativa, Pneumonia, Pediatric

Brief summary

Complementary and adjunctive therapies are increasingly being explored to enhance asthma control and reduce airway inflammation. Nigella sativa (black seed) is a medicinal plant used traditionally in multiple regions and has demonstrated anti-inflammatory, immunomodulatory, and bronchodilator effects. Its potential as an adjuvant therapy in asthma has attracted attention in both preclinical and clinical research

Detailed description

We hypothesize that supplementation with Nigella sativa will lead to improved asthma control scores and enhanced pulmonary function parameters in this population.

Interventions

DIETARY_SUPPLEMENTNigella sativa Oil Capsules (100 mg/kg/day)

Nigella sativa oil administered orally in capsule form at a dose of 100 mg/kg/day as adjunct therapy.

DIETARY_SUPPLEMENTNigella sativa Oil Capsules (50 mg/kg/day)

Nigella sativa oil administered orally in capsule form at a dose of 50 mg/kg/day as adjunct therapy.

DRUGFluticasone / Long-Acting Beta-2 Agonist Combination

Low-dose inhaled corticosteroid (fluticasone propionate 200 µg/day) combined with a long-acting beta-2 agonist (two puffs every 12 hours), administered via metered-dose inhaler with spacer.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Inclusion criteria

1. Children aged 6-18 years 2. Diagnosed with moderate persistent asthma according to the Global Initiative for Asthma (GINA) 2022 guidelines 3. Receiving stable standard controller therapy (inhaled corticosteroids ± long-acting β2-agonists) for at least 4 weeks prior to enrollment 4. Able to perform reproducible spirometry

Exclusion criteria

1. History of severe asthma exacerbation requiring ICU admission in the past 3 months 2. Use of systemic corticosteroids within 4 weeks prior to enrollment 3. Known hypersensitivity to Nigella sativa or its components 4. Other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis) 5. Significant comorbidities (e.g., cardiac, renal, or hepatic disorders) 6. Inability to comply with study procedures

Design outcomes

Primary

Measure	Time frame	Description
Asthma Control Questionnaire (ACQ)	12 weeks	—
Forced Expiratory Volume in 1 second (FEV₁)	12 weeks	Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Forced Vital Capacity (FVC)	12 weeks	Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
FEV₁/FVC ratio	12 weeks	Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Peak Expiratory Flow (PEF)	12 weeks	Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026